Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients With Relapsing Forms of Multiple Sclerosis (TERIKIDS)
To assess the effect of teriflunomide in comparison to placebo on disease activity measured by time to first clinical relapse after randomization in children and adolescents 10 to 17 years of age with relapsing forms of multiple sclerosis.
- To assess the effect of teriflunomide in comparison to placebo on disease activity/progression measured by brain MRI and on cognitive function.
- To evaluate the safety and tolerability of teriflunomide in comparison to placebo.
- To evaluate the pharmacokinetics (PK) of teriflunomide.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Two Year, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of Teriflunomide Administered Orally Once Daily in Pediatric Patients With Relapsing Forms of Multiple Sclerosis Followed by an Open-Label Extension|
- Time to first clinical relapse after randomization [ Time Frame: over 96 weeks ]
- Proportion of relapse free patients [ Time Frame: at 24, 48, 72 and 96 weeks ]
- Number of of new/newly enlarged T2 lesions [ Time Frame: at 24, 48, 72 and 96 weeks ]
- Number of T1 Gd-enhancing T1 lesions [ Time Frame: over 96 weeks ]
- Change in volume of T2 lesions [ Time Frame: over 96 weeks ]
- Change in volume of T1 hypointense lesions [ Time Frame: over 96 weeks ]
- Number of new T1 hypointense lesions [ Time Frame: over 96 weeks ]
- Proportion of patients free of new or enlarged MRI T2-lesions [ Time Frame: at 48 weeks and 96 weeks ]
- Brain atrophy [ Time Frame: over 96 weeks ]
- Change in performance on symbol digit modalities test (SDMT) and Cognitive Battery Test [ Time Frame: at randomization, then every 24 weeks (SDMT only) and at 96 weeks ]
- Safety, as assessed by clinical, laboratory, ECG, and vital signs events [ Time Frame: over 96 weeks ]
- Assessment of PK parameter - lowest concentration of drug in the blood measured after dosing (Ctrough) [ Time Frame: at Weeks 2, 3, 4, 8, 12, 24, 36 and 96 ]
|Study Start Date:||July 2014|
|Estimated Study Completion Date:||August 2021|
|Estimated Primary Completion Date:||October 2017 (Final data collection date for primary outcome measure)|
Placebo Comparator: placebo
Matching placebo tablets
Pharmaceutical form:tablet Route of administration: oral
teriflunomide oral tablet, three dosages (3.5, 7 or 14 mg) to reach 14 mg adult equivalent
Drug: Teriflunomide HMR1726
Pharmaceutical form:film-coated tablet Route of administration: oral
- A screening period up to 4 weeks
- A double-blind treatment period of up to 96 weeks for each patient
- An open-label period including the remainder of the initial 96 weeks, where applicable, and a 96-week extension, ie, up to a maximum of 192 weeks after randomization
- A follow-up period of 4 weeks for patients discontinuing treatment
Within the 96 weeks double-blind treatment period, the first 4 weeks are pharmacokinetic (PK) run-in phase in which PK samples (blood samples) will be collected from patients and then 4 weeks of analysis (no samples drawn). The PK run-in phase (total 8 weeks) is intended to provide individual PK parameters to allow the dose adjustment to the 14mg adult-equivalent dose for the rest of the study.
Patients experiencing a relapse after the PK run-in phase (8 weeks) and if confirmed by the Relapse Adjudication Panel (RAP) and patients fulfilling MRI criteria (high number of new lesions at week 36, 48 or 72 compared to previous images) will have the option to continue in an open label teriflunomide treatment arm up to 192 weeks from randomisation.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02201108
|Contact: For site information, send an email with site number to||Contact-Us@sanofi.com|
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|Study Director:||Clinical Sciences & Operations||Sanofi|